JP2020503981A - Medical device handle and associated method - Google Patents

Abstract

The insertion device according to the invention has a body, a delivery shaft and a holder. The body includes a longitudinal axis aligned with the central axis of the proximal end of the delivery shaft. The holder is coupled to the body and includes a medical device receiving chamber. The medical device receiving chamber has a longitudinal axis that is non-parallel to the longitudinal axis of the body. The medical device receiving chamber has a semi-circular shape and is located on the upper part of the holder. The holder further includes a stop surface that forms an extension of the medical device receiving chamber.

Description

  Various aspects of the present disclosure generally relate to medical devices. More specifically, the present disclosure relates to medical devices and attachment configurations for medical devices.

  Medical devices, such as expandable baskets and retrieval devices, include a shaft and are configured to be delivered through a working channel of an insertion device (eg, an endoscope). By selectively extending or retracting the shaft of such a medical device relative to the working channel of the insertion device, i.e., the distal end of the sheath of the insertion device, the shaft can be deployed and retracted, One or more treatments, treatments, or diagnostic evaluations are performed on the subject. For example, a medical device includes a shaft that terminates on a distal side with an end effector, such as an expandable basket.

  However, in order to extend or retract the end effector while being coupled to the endoscope, it may be difficult or complicated to maintain separate components, or may require multiple users. May be. The devices and methods of the present disclosure rectify some of the disadvantages described above and / or address other aspects of the prior art.

  Embodiments of the present disclosure relate inter alia to medical devices. Each of the embodiments disclosed herein may include one or more features described in connection with any other embodiments disclosed.

  In one embodiment, the insertion device includes a body and a delivery shaft, the body including a longitudinal axis aligned with a central axis of a proximal end of the delivery shaft, and the insertion device further includes a body attached to the body of the insertion device. Including the coupled holder, the medical device receiving chamber has a longitudinal axis that is non-parallel to the longitudinal axis of the body.

  The insertion device can further include one or more of the following features. The medical device receiving chamber has a semi-circular shape and is located on the upper part of the holder. The holder further includes a stop surface forming an extension of the handle chamber. The stop surface has a semi-circular shape that aligns with the semi-circular shape of the receiving chamber. The stop surface is narrower and / or shallower than the medical device receiving chamber.

  The insertion device further includes a mounting surface. The holder further includes a finger ridge opposite the mounting surface. The mounting surface is coupled to the rounded portion of the body. The mounting surface includes a slot, a shallow groove, or a protrusion. The holder is coupled to a proximal portion of the body. The insertion device further includes an offset lever for offsetting the distal end of the delivery shaft, and the holder is coupled to the body of the insertion device on the opposite side of the offset lever. The insertion device further includes a medical device coupled to the insertion device via the holder. The medical device includes a shaft introduced within a delivery shaft. The medical device receiving chamber of the holder includes a female connector and further includes an alignment groove. The body of the insertion device includes a hole, and the holder further includes a distal extension and a holder pin that fits within the hole of the insertion device to assist in coupling the holder to the insertion device. The medical device includes a male connector and an alignment pin coupled to the insertion device via the holder.

  In another embodiment, an insertion device includes a body and a delivery shaft extending from the body, and a medical device holder coupled to one of the body or the delivery shaft. The medical device holder can include a handle chamber and a stop surface having an edge facing the handle chamber.

  The insertion device may further include one or more of the following features. The medical device holder can further include a mounting surface, which can be coupled to a proximal portion of the body. The holder may further include at least two legs each having a through hole. The holder can be coupled to the delivery shaft, which passes axially through the through hole at at least two legs.

  In another embodiment, an insertion device includes a body having a distal portion, a middle portion, and a proximal portion, a delivery shaft extending from the distal portion, and a proximal shaft for biasing a distal end of the delivery shaft. A deflection lever on the portion and a medical device holder coupled to the proximal portion can be included. The medical device holder can be coupled to a proximal portion of the body opposite the deflection lever. The insertion device can further include a medical device coupled to the medical device holder, and the medical device can include a handle, a plunger, and a shaft coupled to a distal end of the plunger.

  The above summary and the following detailed description are exemplary and explanatory only, and are not restrictive of each feature as claimed. As used herein, the term “comprising,” “comprising,” or variations thereof, means that a process, method, article, or device that includes an element list does not include only these elements, but expressly It is intended to cover the generic inclusion so that it may include other elements not listed or specific to such a process, method, article, or device. Further, the term "exemplary" is used in the present invention to mean "exemplary" rather than "ideal." As used herein, the terms "about," "substantially," and "approximately" refer to a range of values that is within +/- 5% of the stated value.

  The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary features of the disclosure and, together with the description, serve to explain the principles of the disclosure.

Fig. 3 illustrates a medical device coupled to an insertion device via an exemplary holder. FIG. 2 is a perspective view of the exemplary holder of FIG. 1. FIG. 11 illustrates a medical device coupled to an insertion device via a variant holder according to aspects of the present disclosure. FIG. 4 is a perspective view of the holder of FIG. 3. FIG. 11 illustrates a medical device coupled to an insertion device via a variant holder according to aspects of the present disclosure. It is a perspective view of the holder of FIG. FIG. 4 is a partial exploded view of a medical device, an insertion device, and an alternative holder according to aspects of the disclosure. FIG. 5 illustrates an additional medical device element according to aspects of the disclosure. FIG. 9 is a perspective view of a medical device coupled to an insertion device via an alternative holder according to aspects of the present disclosure. FIG. 11 illustrates a medical device coupled to an insertion device via a variant holder according to aspects of the present disclosure. FIG. 7 illustrates two medical devices coupled to an insertion device via a modified holder according to aspects of the present disclosure. FIG. 11B is a detailed view of a part of FIG. 11A. FIG. 9 is a perspective view of a medical device coupled to an alternative holder according to an aspect of the present disclosure.

  Embodiments of the present disclosure relate to a medical device holder that couples a medical device to an insertion device to deploy a shaft from the medical device. The medical device can include any type of end effector or retrieval device, such as an expandable retrieval basket.

  Reference will now be made in detail to the embodiments of the present disclosure described above and shown in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

  The terms “proximal” and “distal” are used herein to refer to the relative positions of the components of an exemplary medical device or insertion device. As used herein, "proximal" refers to a location relatively close to the outside of the body or relatively close to the operator using the medical device or insertion device. In contrast, "distal" refers to a location that is relatively far from the operator using the medical device or insertion device, or that is relatively close to the inside of the body.

  FIG. 1 shows a medical system 10, which includes an insertion device 12, a medical device 14, and a holder 16. The insertion device 12 includes a body 18 and a delivery shaft 20, which includes a deflection lever 22 and at least one port 24. The medical device 14 includes a handle 26, a shaft 28, an end effector 29, and an actuator or plunger 30. Shaft 28 is at least partially surrounded by sheath 31. The holder 16 is coupled to the insertion device 12 and the medical device 14 is mounted on the holder 16 proximate the deflection lever 22.

  The insertion device 12 can be a ureteroscope (eg, Lithovue® single-use digital flexible ureteroscope by Boston Scientific Corp.), an endoscope, a hysteroscope, a bronchoscope, a cystoscope, or any similar The device is good. The insertion device 12 may be single use, ie, disposable, or reusable. The body 18 of the insertion device 12 has a distal portion 32, an intermediate portion 34, and a proximal portion 36. The body 18 has a longitudinal axis A aligned with the central axis of the proximal end of the delivery shaft 20. The biasing lever 22 is positioned at the rounded corner of the proximal portion 36 and is operable to bias the distal end 38 of the delivery shaft 20. The intermediate portion 34 may have a substantially constant diameter and form a portion of the insertion device 12 that is gripped by the user such that the thumb of the user is near the biasing lever 22. At least one port 24 may be positioned on distal portion 32. The at least one port 24 may be a T-shaped connector as shown in FIG. 1, a Y-shaped connector, or any other suitable connector. The port 24 may have a thread or may be a luer component. At least one port 24 may be connected to delivery shaft 20 via at least one internal lumen (not shown) of body 18 of insertion device 12. In addition, a joint 40 that forms a seal over port 24 may be coupled to at least one port 24, such as a gateway joint. Although not shown, the insertion device 12 may include an integrated camera at the distal end 38, which is connected to processing software and a display via a communication and power conduit 42. Good.

  Although the medical device 14 is described as a retrieval basket device, the medical device 14 is any type of medical device used to deliver a drug treatment to a target site within a subject in connection with the insertion device 12, It should be understood that For example, medical device 14 is alternatively a laser fiber, irrigation and / or suction tube, snare, forceps, and / or a needle.

  The shaft 28 of the medical device 14 may be movable to extend or retract the end effector at the distal end of the shaft 28. Shaft 28 is coupled to the distal end of plunger 30, and movement of plunger 30 relative to handle 26 extends or retracts shaft 28. Alternatively, shaft 28 may be coupled to a proximal portion of plunger 30 and shaft 28 and / or a shaft connector (not shown) may extend proximally beyond the proximal end of plunger 30. It may extend to allow user operation, for example, to connect a laser fiber or irrigation and / or suction tube to an external source. The plunger 30 further includes a plunger knob 44 at the proximal end of the plunger 30, for example, to assist operation by a user's finger. The plunger 30 is movable in the axial lumen of the handle 26, and movement of the plunger 30 through the handle 26 is further applied by a biasing member (not shown) such as, for example, a helical (compression) spring. It is good to be urged. The handle 26 also includes a handle knob 46 at the proximal end of the handle 26, for example, to aid manipulation by a user's finger. In an embodiment not shown, plunger 30 includes at least one plunger pin, and handle 26 includes at least one pin receiving slot, and movement of at least one plunger pin within the at least one pin receiving slot causes Axial and rotational movement of the plunger 30 relative to the handle 26 is limited or locked.

  The shaft 28 is at least partially surrounded by a sheath 31 that moves the shaft 28 relative to the sheath 31 by movement of the plunger 30 relative to the handle 26, such as at a distal end of the handle 26. 26. The shaft 28 is inserted through the fitting 40 and / or the port 24 together with the sheath 31.

  As shown in FIG. 1, the holder 16 is coupled to the insertion device 12, and the medical device 14 is mounted on the holder 16. The holder 16 is positioned on the proximal portion 36 of the insertion device 12 and on the opposite corner of the deflection lever 22. Holder 16 may be permanently attached via an adhesive, a screw, or another fastener. Holder 16 may also be removably attached via straps, tape, Velcro®, clamps, snaps, or the like. The holder 16 may also be molded into the insertion device 12 or may be formed integrally with the insertion device 12.

  In one aspect, when attaching the medical device 14 to the holder 16, the plunger 30 may be positioned proximal to the deflection lever 22. In addition, the shaft 28 and the sheath 31 have a predetermined length such that when the shaft 28 and the sheath 31 are attached to the holder 16, the distal ends of the shaft 28 and the sheath 31 are delivered. The length may be flush with the distal end 38 of the shaft 20 or may be close to it. In this case, the pushing action on plunger 30 serves to extend the distal end of shaft 28 distally outside sheath 31 and from distal end 38 of delivery shaft 20. In another aspect, the shaft 28 and the sheath 31 have a predetermined length such that when attached to the holder 16 the distal end of the shaft 28 and the sheath 31 The length extends distally beyond portion 38. In this case, the shaft 28 and sheath 31 may extend beyond the delivery shaft 20 to reach the target material. In addition, the user may adjust the distance that the shaft 28 and the sheath 31 extend beyond the distal end 38 by adjusting the portion of the shaft 28 and the sheath 31 proximal to the joint 40. Good.

  As shown in FIG. 2, the holder 16 includes a handle chamber 48, a stop surface 50, and a mounting surface 52. Handle chamber 48 receives a medical device by engaging or engaging the outer surface of handle 26 of medical device 14. The handle chamber 48 may have a semi-circular shape and may be located on the rounded upper portion 54 of the holder 16. The handle chamber 48 includes a longitudinal axis B that is non-parallel to the longitudinal axis A of the body 18 of the insertion device 12 (FIG. 1). The stop surface 50 may also have a semi-circular shape and is located on the upper portion 54, but may be narrower and shallower than the handle chamber 48. The stop surface 50 forms an extension of the front edge of the handle chamber 48 and accommodates a distal tip of the handle 26 that is smaller in size than the main body of the handle 26 of the medical device 14. The semi-circular shape of the stop surface 50 may be aligned with the semi-circular shape of the handle chamber 48. The stop surface 50 stabilizes the handle 26 during movement of the plunger 30. Upper portion 54 may be wider than middle portion 56 and lower portion 58. The intermediate portion 56 includes a through hole 60. The mounting surface 52 may be shaped to coincide with the portion of the insertion device 12 where the holder 16 is mounted. In one embodiment, shown in FIG. 2, the mounting surface 52 includes a flat lower portion 57 and a curved upper portion 59 that matches the curvature of the proximal portion 36 of the insertion device 12. The side of the lower portion 58 opposite the mounting surface 52 has a curved lower portion, a substantially flat middle portion, and an outwardly curved upper portion to form a finger ridge 62. Good.

  Mounting surface 52 may include additional components that couple holder 16 to insertion device 14. For example, mounting surface 52 includes slots for screws, straps, or other fasteners as described above. Mounting surface 52 may also be flat or include a shallow groove to adhere holder 16 to insertion device 12. In another embodiment, the mounting surface 52 includes extensions or protrusions at the front end 64 and rear end 66 such that the holder 16 can be snapped onto the insertion device 12 between the extensions or protrusions, or 12 or otherwise attached to the insertion device 12.

  In use, the delivery shaft 20 of the insertion device 12 is inserted into a subject to a surgical site. The holder 16 may be coupled to the insertion device 12 before insertion, or may be coupled to the insertion device 12 after insertion. The medical device 14 is then inserted into the insertion device 12 through the port 24, with or without the fitting 40, and the shaft 28 and sheath 31 are moved slightly proximal to the distal end 38 of the delivery shaft 20, or , Flush with or distal to the distal end 38. Shaft 28 and sheath 31 may be introduced into insertion device 12 using an introducer sheath (not shown), and the shaft may be rapidly introduced into port 24. The medical device 14 may be coupled to the insertion device 12 by a handle 16 that fits into the holder 16.

  Movement of the deflection lever 22 causes the distal end 38 of the delivery shaft 20 to be shifted proximally of the surgical site. The user can then easily extend and / or rotate the shaft 28 by actuation of the plunger 30 and the plunger knob 44 because the medical device 14 is positioned proximally of the deflection lever 22 to provide drug treatment. Deliver. After delivering the drug treatment, plunger 30 is retracted proximally and shaft 28 and sheath 31 are retracted into distal end 38 of delivery shaft 20. As discussed above, the biasing member enclosed within handle 26 may bias plunger 30 back proximally. For example, if multiple surgical sites are present or the target tissue moves, the deflection and extension steps are repeated; otherwise, the medical device 14 and the insertion device 12 are removed from the subject. Alternatively, the medical device 14 may be removed from the insertion device 12 and another medical device may be inserted into the insertion device 12 and coupled via the holder 16 to deliver further medication. Also, if the holder 16 is removably coupled to the insertion device 12, the holder 16 may be separated from the insertion device 12 and a different holder may be coupled to the insertion device 12 to accommodate different medical devices.

  FIG. 3 illustrates another aspect of the present disclosure with components similar to the medical system 10 by adding 100 to the reference numbers. The medical system 110 includes an insertion device 112, a delivery shaft 120, a deflection lever 122, a port 124, and a communication and power conduit 142, which performs functions similar to the insertion device 12 of FIG. L-shaped insertion device 112 having the same. As in the previous embodiment, the medical device 114 is inserted into the insertion device 112 through the port 124 with or without the fitting 140 and the shaft 128 and sheath 131 are moved proximally of the distal end 138 of the delivery shaft 120. Or flush with this.

  The medical device 114 is coupled to the insertion device 112 via the holder 70 in a manner similar to that discussed in connection with FIG. 1 and the proximal corner of the insertion device 112 at the opposite corner of the deflection lever 122. Positioning on the part 136. 1, when mounting the medical device 114 to the holder 70, the plunger 130 is positioned proximal to the deflection lever 122. The shaft 128 having the end effector 129 and the sheath 131 have a predetermined length such that when attached to the holder 70, the distal ends of the shaft 128 and the sheath 131 become the distal end of the delivery shaft 120. The length may be flush with portion 138, may be proximal, or may extend distally beyond it. Pushing plunger 130 at this time helps to extend the distal end of shaft 128 distally from distal end 138 of delivery shaft 120 out of sheath 131.

  As shown in FIG. 4, the holder 70 includes a handle chamber 148, a stop surface 150, and a mounting surface 152. The handle chamber 148 may engage or engage the outer surface of the handle 126 of the medical device 114. The handle chamber 148 may be semi-circular, cut from the rounded upper portion 154 of the holder 70. Stop surface 150 may be semi-circular cut from upper portion 154, and upper surface 150 is narrower and shallower than handle chamber 148. Stop surface 150 extends from the leading edge of handle chamber 148 and accommodates a distal tip or portion of handle 126 that is smaller in size than the body of handle 126 of medical device 114. Stop surface 150 stabilizes handle 126 during movement of plunger 130. Upper portion 154 may be wider than middle portion 156 and lower portion 158. The intermediate portion 156 may include a through hole 160 and two supports 72 connecting the mounting surface 152 to the handle chamber 148. The mounting surface 152 may also be shaped to coincide with a portion of the insertion device 112 on which the holder 70 is mounted. In one embodiment, shown in FIG. 4, the mounting surface 152 includes a substantially flat lower portion such that the mounting surface 152 conforms to the shape of the proximal portion 136 of the insertion device 112.

  Mounting surface 152 may include additional components that couple holder 70 to insertion device 112 as described with respect to holder 16.

  As shown in FIG. 3, the medical device 114 includes a handle 126, a shaft 128, a plunger 130, and a sheath 131, and functions in a manner similar to the medical device 114 described above. Sheath 131 at least partially surrounds shaft 128 and is coupled to the distal end of handle 126. In one aspect, the plunger 130 includes a pin 76 and the handle 126 includes a track 78 having at least one tab 80 so that the plunger 130 can be lockably positioned within the handle 126. The portion of the shaft 128 and sheath 131 proximate the joint 140 determines the position of the shaft 128 and sheath 131 relative to the distal end 138 of the insertion device 112. In this aspect, the position of plunger 130 with respect to handle 126 determines the position of shaft 128 with respect to sheath 131. At this time, the user deviates the distal end 138 of the insertion device 112 via the deviating lever 122 and simultaneously extends and / or rotates the shaft 128 using only two hands.

  5 and 6 illustrate another embodiment of the present disclosure with components similar to the medical system 10 by adding 200 to the reference numbers. The medical system 210 of FIG. 5 includes an insertion device 212 and a medical device 214 similar to that of FIG. FIG. 5 also includes a holder 82 that couples the medical device 214 to the insertion device 212.

  As shown in FIG. 6, the holder 82 includes at least two legs 84 and a holder body 86. The leg 84 includes an axial through hole 88. The through hole 88 is dimensioned such that the delivery shaft 220 of the insertion device 212 fits into the through hole 88 and slides axially therein (see FIG. 5). The holder body 86 is non-parallel to the axial through-hole 88 of the leg 84, ie, forms an angle. Holder body 86 is generally cylindrical and includes a central lumen that mates or engages the outer diameter of handle 226 of medical device 214. One end of the holder body 86 is completely open so that the holder body 86 receives the handle 226. The holder body 86 also includes an open slot 90 on the upper surface of the holder body 86 opposite the legs 84. Open slot 90 is sized such that shaft 228 fits into open slot 90. The open slot 90 is also connected to a stop surface 92 at a partially closed end of the holder body 86. Stop surface 92 houses the distal tip of handle 226 and stabilizes handle 226 during movement of plunger 230 of medical device 214.

  As shown in FIG. 5, the holder 82 is attached to the delivery shaft 220 of the insertion device 212, and the delivery shaft 220 passes through the through hole 88 of the leg 84 in the axial direction. Medical device 214 is positioned within holder body 86. The shaft 228 having the end effector 229 is at least partially surrounded by the sheath 231 and is inserted into the insertion device 212 via the port 224 with or without the joint 240, as described above. The shaft 228 and sheath 231 of the medical device 214 have a predetermined length such that the length of the shaft 228 and the distal end of the sheath 231 when the medical device 214 is secured in the holder 82. The length may be proximal to the distal end 238 of the shaft 220, may be flush therewith, or may be positioned distally beyond it. It may be. Next, the user operates the deflection lever (not shown) with the thumb to operate and shift the insertion device 212 with one hand. The user then holds the delivery shaft 220 between the legs 84 using the thumb and middle finger of the other hand of the user. The user guides the holder 82 along the outer diameter of the delivery shaft 220 to determine orientation and / or secure. The position of the holder 82 on the delivery shaft 220 is adjusted to adjust the position of the shaft 228 and the distal end of the sheath 231 relative to the distal end 238 of the delivery shaft 220. The user activates the plunger 230 using the index finger of the same hand, for example, to activate the medical device 214 to extend the shaft 228. The portion of shaft 228 and sheath 231 that extends proximally of fitting 240 determines the position of shaft 228 and sheath 231 relative to distal end 238 of insertion device 212. Again, extending the shaft 228 by action on the plunger 230 may be biased by a biasing member, and to lockably position the plunger 230, the plunger 230 includes a pin and the handle 226 includes , A track having at least one slot. It should be noted that during operation of the medical device 214, the user's thumb and index finger may be removed from the delivery shaft 220 to further steer the medical device 214, as described above.

  FIG. 7 illustrates another embodiment of the present disclosure with components similar to the medical system 10 by adding 300 to the reference numbers. As shown, the medical system 310 includes an insertion device 312 and a medical device 301 coupled to the insertion device 312 via a holder 303. The insertion device 312 may have a shape and function similar to the insertion device 12 of FIG. 1, including the delivery shaft 320, the deflection lever 322, the port 324, and the communication and power conduit 342. A fitting (not shown) may be attached to port 324, as described above. The body 318 of the insertion device 312 has a distal portion 332, an intermediate portion 334, and a proximal portion 336. The intermediate portion 334 may be of substantially constant diameter and may form a portion of the insertion device 312 that can be gripped by the user such that the user's thumb is near the deflection lever 322. Proximal portion 336 may be wider than intermediate portion 334 and deflection lever 322 may be positioned at a rounded corner of proximal portion 336.

  The medical device 301 includes a handle 305, a shaft 307, and a plunger 309. Shaft 307 may be coupled to a distal portion of plunger 309. Further, shaft 307 is at least partially surrounded by sheath 311, which is coupled to a distal portion of handle 305. Handle 305 includes an axial lumen and a trigger 313 that extends laterally away from the axial lumen. Handle 305 also includes a track 315 having at least one slot 317. Handle 305 also surrounds a biasing member (not shown), such as, for example, a helical (compression) spring, which biases the movement of plunger 309 within the axial lumen of handle 305. Plunger 309 may include an axial plunger shaft 319 having plunger pins 321. The plunger pin 321 may be a cantilevered protrusion that extends laterally away from the plunger shaft 319, and the plunger pin 321 has an inclined portion (not shown) aligned with the track 315 of the handle 305. May be introduced into the handle 305 via the. Plunger pin 321 is positioned within track 315 and is movable within track 315 and is lockable within slot 317. Slot 317 may extend circumferentially from track 315 and may extend from track 315 in two directions. In one non-illustrated embodiment, handle 305 includes an additional track having at least one slot, wherein the additional track and slot are mirror images of track 315 and throttle 317 on a circumferentially opposite side of handle 305. Make In this case, the plunger 309 further includes an additional plunger that is movable and lockable in additional tracks and slots.

  Plunger 309 may further include a laterally extending trigger stop 323 that aligns with trigger 313 and assists in connecting plunger 309 to holder 303. Plunger 309 may also include alignment pins 325 and male connector 327, thereby coupling plunger 309, ie, medical device 301, to insertion device 312.

  Holder 303 is coupled to insertion device 312 at the opposite side of deflection lever 322 at proximal portion 336. For example, holder 303 may be shaped to mate with insertion device 312 and match the contour of intermediate portion 334 and a portion of proximal portion 336 that is wider. In addition, holder 303 may include holder pins 329 in distal and proximal positions, which fit into recesses or holes 331 in intermediate portion 334 or proximal portion 336 of insertion device 312 and snap into place. Stopped or otherwise secured. In one embodiment, holder 303 includes a biasable or flexible extension 330 coupled to holder pin 329 to position holder pin 329 in aperture 331 to couple holder 303 to insertion device 312. When doing so, the extension 330 may bend or flex.

  Holder 303 may also include female connector 333 and alignment groove 335. Medical device 301 is coupled to holder 303 by coupling male connector 327 to female connector 333. Alignment pin 325 is also coupled to alignment groove 335 to secure plunger 309 and prevent rotation during operation.

  As described above, when coupling the medical device 301 to the insertion device 312 via the holder 303, the user operates the medical system 310 with one hand. In this embodiment, the shaft 307 is at least partially surrounded by the sheath 311, wherein the shaft 307 and the sheath 311 have a predetermined length, such length coupling the shaft 307 and the sheath 311 to the insertion device 312. When enabled, the shaft 307 and sheath 311 may be of a length that is flush with the distal end of the delivery shaft 320, or of a length that is slightly proximal or distal thereof. It may be. The portion of shaft 307 and sheath 311 extending proximally of port 324, which may include a fitting, determines the position of shaft 307 and sheath 311 relative to the distal end of insertion device 312.

  The user may hold the insertion device 312 such that the user's thumb is near the biasing lever 322, such that the user's finger wraps around the middle portion 334 of the insertion device 312. In this position, the user's index finger is near the trigger 313 of the medical device 301, particularly the handle 305. The user biases the distal end of delivery shaft 320 via the user's thumb acting on biasing lever 322 to position distal end 338 at the target site. The user extends the shaft 307 and the sheath 311 from the distal end, and then extends the shaft 307 out of the sheath 311 by movement of the trigger 313 toward the insertion device 312. For example, if the shaft 307 includes a self-expanding retrieval basket at the distal end as an end effector, the basket may be expanded when the sheath 311 is retracted (shown in dashed lines in FIG. 7). The user may further lock the shaft 307 in the extended position by rotating the trigger 313 to lock the pin 321 of the plunger shaft 319 into the slot 317. As mentioned above, the slots 317 may extend circumferentially from the track 315 in two directions, thereby allowing left-handed and right-handed operation. The plunger 309 is fixed to the holder 303 by the interaction of the alignment pin 325 and the male connector 327 with the alignment groove 335 and the female connector 333. The user then positions handle 305 such that plunger pin 321 is within track 315 and removes the force on trigger 313 such that a biasing member (not shown) moves trigger 313 away from the insertion device. Pushing the shaft 307 to its original position retracts the shaft 307 into the sheath 311. The medical device 301 may be removed from the insertion device 312 to remove any captured material.

  It should be noted that the length of track 315 and the location and number of slots 317 may vary depending on shaft 307. For example, the truck 315 and slot 317 shown in FIG. 7 are used with a zero tip self-expanding retrieval basket.

  FIG. 8 shows another embodiment of a handle 305 'that can be implemented in a manner similar to that described in connection with FIG. For example, sheath 311 is coupled to a distal portion of handle 305 '. Handle 305 'includes an axial lumen and a trigger 313 that extends laterally away from the axial lumen. Handle 305 'also includes track 337. The track 337 includes a main axially extending slot 339 and at least two circumferentially extending tabs 341 on which the plunger pin 321 can be lockably positioned. Track 337 also includes a cross slot 343 extending perpendicular to main slot 339 and at least two release slots 345 extending from cross slot 343 parallel to main slot 339. It should be noted that tab 341, cross slot 343, and release slot 345 form a mirror image for both left-handed and right-handed operations. It should also be noted that the handle 305 'may include a track of the same shape on the circumferentially opposite side of the handle 305'. The length of the main slot 339 defines the stroke length for the trigger 313. Further, the location and length of the main slot 339, tab 341, cross slot 343, and release slot 345 may be selected to correspond to the changing position of the end effector at the distal end of the sheath 307. The effector is, for example, a hybrid gripper collection basket.

  FIG. 9 illustrates another embodiment of the present disclosure with components similar to the medical system 10 by adding 400 to the reference numbers. As shown, the medical system 410 includes an insertion device 412 and a medical device 414 coupled to the insertion device 412 via the holder 401. The insertion device 412 may operate as described above for other embodiments. The medical device 414 may include a slot body 403 and a plunger 405, and movement of the plunger 405 relative to the slot body 403 is biased by a biasing member (not shown) such as a helical (compression) spring. Plunger 405 includes a trigger 407 that projects laterally from plunger 405, and slot body 403 includes a main slot 409. The trigger 407 moves in the main slot 409 to move the plunger 405 with respect to the slot main body 403.

  The holder 401 may have a shape similar to that of the holder 303 in FIG. The holder 401 may be shaped to be fixedly coupled to the intermediate portion 434 and the proximal portion 436 of the insertion device 412 so that the holder 401 is positioned on the opposite side of the deflection lever 422. You. Holder 401 may include a female connector (not shown) for receiving slot body 403 on the opposite side of insertion device 412. As a modification, the slot body 403 may be formed integrally with the holder 401. Although not shown, the holder 401 may further include holder pins that couple the holder 401 to the insertion device 412 via holes, as described with respect to FIG. Holder 401 may also be coupled to insertion device 412 by any of the connections described above.

  In this embodiment, a shaft (not shown) is at least partially surrounded by a sheath 411. The shaft is coupled to the inner lumen of the slot body 403. Sheath 411 is coupled to the inner lumen of plunger 405. In this case, the operation of the trigger 407 through the main slot 409 moves the plunger 405 with respect to the slot main body 403, retreats the sheath 411, and extends the shaft. If the shaft includes a self-expanding retrieval basket at the distal end as an end effector, the retrieval basket expands when actuation on trigger 407 causes sheath 411 to retract. Releasing the force on the trigger 407 encloses the retrieval basket within the sheath 411.

  In another non-illustrated aspect of the present disclosure, the slot body 403 includes a tab extending from the main slot 409 that lockably positions the trigger 407 to lock the shaft in the extended position. Slot body 403 may also include a release slot, as described above.

  FIG. 10 illustrates another embodiment of the present disclosure with components similar to the medical system 10 by adding 500 to the reference numbers. As shown, the medical system 510 includes an insertion device 512 and a medical device 501, 514 coupled to the insertion device 512 via a double holder 513 and inserted through the through port 524. The insertion device 512 may operate as described above in connection with other embodiments. The medical device 501 may have a shape and function substantially similar to the medical device 301, include a track 537 having a plurality of tabs 541, and are arranged as shown in FIG. The medical device 514 may have a shape and function substantially similar to the medical device 14 and includes a handle 526 and a plunger 530. The double holder 513 may have a shape similar to the holder 303 of FIG. 7, but may be attached to the insertion device 512 by an additional protrusion forming a part similar to the holder 16 of FIG. Thus, the user can couple the two medical devices 501, 514 to the insertion device 512.

  The medical device 501 may include a handle 505, a shaft (not shown), and a plunger 509, and a sheath 511 at least partially surrounds the shaft and is coupled to a distal portion of the handle 505. The user may also manipulate a portion of the shaft and sheath 511 that extends proximally of the port 524 to determine the position of the shaft and sheath 511 relative to the distal end of the insertion device 512, where the port 524 is , A joint 540. In this case, the user positions the shaft and sheath 511 relative to the distal end of the insertion device 512 and actuates the handle 505 and the plunger 509 to retract the sheath 511 to expose the shaft, thereby causing the retrieval device to retract. Enable expansion. The user operates the plunger 509 relative to the handle 505 to lock the plunger pin (not shown) into one of the plurality of tabs 541 of the handle 505, thereby causing the sheath 511 to operate, as described above. It is better to lock in the retracted position.

  When the medical device 514 is attached to the insertion device in the holder 16, the medical device 514 may operate as described in connection with the medical device 14. In particular, when the medical device 514 is mounted via the double holder 513, the medical device 514 is positioned on the proximal side of the deflection lever 522. The user may also manipulate a portion of the shaft and sheath 531 that extends proximally of port 524 to determine the position of the shaft and sheath 531 relative to the distal end of insertion device 512, where port 524 is , A joint 540. The user may extend or retract the medical device 514 by actuation on the plunger 530.

  In one embodiment, both medical devices 501, 514 include a retrieval basket. In another example, medical device 501 includes a retrieval basket and medical device 514 includes a laser fiber (not shown). When the medical device 514 includes a laser fiber, the laser fiber may extend proximally from the proximal end of the plunger 530 and may be coupled to a laser source. Alternatively, the plunger 530 may include an adapter at the proximal end, which may couple an additional laser fiber connected to a laser source to a laser fiber included in the medical device 514.

  In use, the user biases the distal end of the insertion device 512 closer to the target material. The user positions one or both of the retrieval basket and the laser fiber relative to the distal end of the insertion device 512 by manipulating a portion of the shaft and sheath that extends proximally of the port 524. The user extends the laser fiber by actuation on the plunger 530 and / or activates the laser source to direct the medical procedure to the target material via the laser fiber, for example, to crush the target material. At this time, the user operates the handle 505 and the plunger 509 to extend and expand the collection basket included in the medical device 501, and capture the target material for removal.

  FIGS. 11A and 11B show a medical system similar to the medical system of FIG. 10, except that the sheaths 511, 531 extend over the length of the shafts 507, 528 extending through the insertion device 512. , 514 shafts 507, 528. For example, when the medical devices 501, 514 are coupled to the insertion device 512 via the double holder 513, the sheaths 511, 531 cause the shafts 507, 528 to connect from the distal ends of the handles 505, 526 to the joint 540 ( (Shown as translucent). In this aspect, the sheaths 511, 531 may also include stops 515, 517 that extend radially outward and are wider than the openings in the fitting 540. In use, the user adjusts the position of the distal end of the insertion device 512, as described above. However, user operation of the shafts 507, 528 and the portion of the sheaths 511, 531 extending proximally of the port 524 is limited by the stops 515, 517. As a result, the user limits the extent to which the shafts 507, 528 extend from the distal end of the insertion device 512.

  For example, if the shaft 528 includes a retrieval basket, the user may place the stop 517 over the sheath 531 at the proximal end of the fitting 540 at the port 524 to allow the user to move the distal end of the insertion device 512. Limit the extension of shaft 528 to the part. The length ratio of the shaft 528 to the sheath 531 positions the retrieval basket flush with the distal end of the insertion device 512 and actuation of the plunger 530 on the medical device handle 526 causes the retrieval basket to be inserted into the insertion device. Extend from the distal end of 512 and expand. Alternatively, if the shaft 528 includes a laser fiber, the user may restrict the shaft 528 to be flush with or slightly proximal of the distal end of the insertion device 512. Using portion 517, actuation of plunger 530 against medical device handle 526 extends the laser fiber from the distal end of insertion device 512 without the risk of overextending the laser fiber at the surgical site. In another aspect, the sheaths 511, 531 completely surround the shafts 507, 531 and limit the extent to which the shafts 507, 528 and sheaths 511, 531 extend from the distal end of the insertion device 512, as described above. Stops 515 and 517 are included.

  FIG. 12 shows a medical system 610 with a medical device 601 and holder 603 similar to the medical devices 301, 414, 501 and holders 303, 401, 513 of FIGS. As shown, the holder 603 is shaped to be coupled to the proximal end of the insertion device and is located on the opposite side of the deflection lever, similar to that shown in FIGS. Holder 603 also includes a distal extension 604 to allow a user to easily hold holder 603 in a user's hand without attaching holder 603 to an insertion device. For example, the distal extension 604 of the holder 603 extends substantially perpendicular to the medical device 601, is generally C-shaped, and includes a curvature that is convex with respect to the medical device 601. The distal extension 604 also has a length approximately equal to the middle portion of the insertion device, similar to the middle portion 334 of FIG. 7, allowing a user to hold the holder 603 or couple the holder 603 to the insertion device. Make it possible.

  The medical device 601 may be coupled to the holder 603 as described for the medical devices 301, 501 and holders 303, 513 in connection with FIGS. As a variant, the medical device 601 and the holder 603 may be formed integrally. Medical device 601 may function as described in connection with medical devices 301, 501. In addition, the medical system 610 may be used separately from the insertion device. For example, when the user inserts the medical device 601 into the target site and holds a pistol-like holder 603, the distal extension 604 is in the user's hand and the user's index finger near the trigger 613. In this case, actuation of the handle 605 on the trigger 613 with respect to the plunger 609 causes the user to extend the shaft 628 from the sheath 631 and expand the end effector 629. The user lockably positions shaft 628 with respect to sheath 631 by positioning plunger pin 621 in tab 641 of track 637.

  Further, the medical system 610 is coupled to the insertion device using a holder 603, as described above in connection with FIG. 7, wherein the holder 603 includes a holder pin 627, which is a recess or hole in a portion of the insertion device. , Snapped, or otherwise secured. In one embodiment, holder 603 includes a biasable or flexible extension 630 coupled to holder pin 627 to position holder pin 627 in the hole of the insertion device to place holder 603 on the insertion device. When coupled, extension 630 may bend or flex. In this case, the medical system 610 may be used as a stand-alone device, as described above, or may be coupled to and inserted into an insertion device.

  The holders 16, 70, 82, 303, 401, 513, 603 of the present disclosure coupling a medical device to an insertion device allow for quick and reliable performance of medical procedures, such as, for example, capturing and removing stones or substances. Help. For example, a user can use one of the holders of the present disclosure to couple an existing medical device to an existing insertion device without requiring new specialized medical equipment. In this case, the user can operate both the distal end of the insertion device and one or both hands extending and / or rotating the shaft of the medical device. In addition, when the medical device is coupled to the insertion device via one of the aforementioned holders, the user can shift the distal end of the insertion device or perform other medical procedures while moving the shaft of the medical device. Can be positioned so as to be lockable. This allows the user to perform other steps with the other hand of the user and reduces the number of users and the time required to perform medical care.

  Although the principles of the present disclosure have been described herein with reference to example aspects directed to particular applications, the present disclosure is not limited to these aspects. Those skilled in the art, having the benefit of the teachings presented herein, will recognize that further modifications, adaptations, aspects, and substitutions with equivalents, all fall within the scope of the aspects set forth herein. . Therefore, the present disclosure should not be regarded as limited by the foregoing description.

Claims (15)

An insertion device,
A body, a delivery shaft, and a holder;
The body includes a longitudinal axis aligned with a central axis of a proximal end of the delivery shaft;
The insertion device, wherein the holder is coupled to the body and includes a medical device receiving chamber, the medical device receiving chamber having a longitudinal axis that is non-parallel to a longitudinal axis of the body.   The insertion device according to claim 1, wherein the medical device receiving chamber has a semi-circular shape and is disposed on an upper portion of the holder.   An insertion device according to claim 1 or 2, wherein the holder further comprises a stop surface forming an extension of the handle chamber.   4. The insertion device of claim 3, wherein the stop surface has a semi-circular shape that aligns with a semi-circular shape of the medical device receiving chamber.   The insertion device according to claim 4, wherein the stop surface is narrower and / or shallower than the medical device receiving chamber.   The insertion device according to claim 1, further comprising a mounting surface.   7. The insertion device of claim 6, wherein the holder further includes a finger ridge opposite the mounting surface.   The insertion device according to claim 6 or 7, wherein the mounting surface is coupled to a rounded portion of the body.   9. The insertion device according to any one of claims 6 to 8, wherein the mounting surface comprises a slot, a shallow groove, or a protrusion.   The insertion device according to any of the preceding claims, wherein the holder is coupled to a proximal portion of the body.   The insertion device further comprises a biasing lever for biasing a distal end of the delivery shaft, the holder being coupled to a body of the insertion device at an opposite side of the biasing lever. Item 11. The insertion device according to any one of Items 1 to 10.   The medical device of any one of claims 1 to 11, further comprising a medical device coupled to the insertion device via the holder, the medical device including a shaft introduced into the delivery shaft. Insertion device.   The insertion device according to claim 1, wherein the medical device receiving chamber of the holder includes a female connector and an alignment groove.   The body of the insertion device includes a hole, and the holder further includes a distal extension and a holder pin that fits into the hole of the insertion device to assist in coupling the holder to the insertion device. 14. The insertion device according to claim 13, comprising:   15. The insertion device according to claim 13, further comprising a medical device coupled to the insertion device via the holder, the medical device including a male connector and an alignment pin.

Images